JACK B. WEINSTEIN, Senior District Judge.
Defendant Eli Lilly & Company ("Lilly") moves for summary judgment against plaintiff Frederick Greaves. Plaintiff, then represented by counsel, commenced this action against Lilly in this court in November 2009.
The present action is essentially a negligence claim, based on a failure to warn. It seeks money damages for injuries, alleging that: (1) Zyprexa, a drug produced by Lilly, caused plaintiffs weight gain and diabetes; (2) Lilly failed to warn of the dangers of Zyprexa; and (3) Zyprexa would not have been prescribed, and plaintiffs injuries would not have been suffered, if proper warnings had been given.
For the reasons indicated below, defendant's motion for summary judgment is granted. As indicated in Part III.C, infra, this case presents a special problem of application of the learned intermediary doctrine under Rhode Island law, not yet clarified in that state.
The present case is part of a massive and highly complex multidistrict litigation that has included claims by individual Zyprexa users, state attorneys general, third-party payors, and other entities alleging physical or financial injury. Some 30,000 cases have been brought against Lilly by individual plaintiffs suffering from serious psychiatric problems who were treated with Zyprexa. Like the present plaintiff, they principally allege that Zyprexa caused deleterious side effects, including excessive weight gain, hyperglycemia, and diabetes; that Lilly misled them and their physicians about the likelihood of these side effects; and that, had they or their attending physicians been aware of the risks, they would not have taken Zyprexa. The court has previously detailed the procedural history and factual background of this multidistrict litigation. See, e.g., Mississippi v. Eli Lilly & Co. (In re Zyprexa Prods. Liab. Litig.), 671 F.Supp.2d 397 (E.D.N.Y. 2009); Blume v. Eli Lilly & Co. (In re Zyprexa Prods. Liab. Litig.), Nos. 04-MD-1596, 06-CV-2782,2009 WL 3596982 (E.D.N.Y. Oct. 20, 2009).
Zyprexa's active ingredient is olanzapine, one of a class of medications known as "atypical" or "second generation" antipsychotics. It was approved for use in treating schizophrenia and acute manic episodes associated with bipolar disorder by the United States Food and Drug Administration ("FDA") in 1996. In 2004, the FDA also approved Zyprexa for the treatment of bipolar disorder generally.
The original 1996 Zyprexa package insert accompanying the drug disclosed information about possible side effects of administration of olanzapine based on clinical trials. The insert provided, in part, the following information:
Zyprexa Package Insert 11 (Oct. 1, 1996) (original emphasis).
Two tables in the insert provided the results of placebo-controlled clinical studies of olanzapine-treated patients. The data indicates that, over a six-week administration of Zyprexa, six percent of olanzapine-treated patients reported weight gain, while only one percent of the placebo-treated patients reported weight gain. Id. at 12-16.
For several years, this information on the insert remained substantially the same insofar as it provided physicians information on reported weight-gain-related adverse events. During this period, the results of longer-term studies and clinical experience with Zyprexa and competing drugs supporting weight gain, hyperglycemia, and diabetes became widely known. See Part Il.B.4, infra.
In May 2000, the FDA undertook an analysis of the incidence of diabetes and hyperglycemia in patients using atypical antipsychotics. The director of the FDA's Division of Neuropharmacological Drug Products requested additional safety information about Zyprexa from Lilly. In its letter, the FDA cited post-marketing reports of diabetes-related adverse events associated with Zyprexa use. In response, Lilly provided the FDA with clinical studies, data analysis, and case report reviews. See In re Zyprexa Prods. Liab. Litig., 253 F.R.D. 69, 119 (E.D.N.Y.2008). There is disagreement about whether the information given by Lilly to the FDA was complete and accurate.
On September 11, 2003, the FDA announced it would require a warning about risks of hyperglycemia and diabetes mellitus and treating precautions to appear in the package insert of all atypical antipsychotics, including Zyprexa. Designed for prescribing doctors, the label noted that epidemiological studies and other information indicated that the relationship between the drug and hyperglycemia and diabetes was not yet fully understood. It reads as follows:
Letter from Russell Katz, M.D., Dep't of Health & Human Servs., to Gregory T. Brophy, Ph.D., Eli Lilly & Co., Sept. 11, 2003, at 1-2. The label did not mention weight gain or diabetes in the "warning to patients" section.
Lilly added the FDA-required language to the Zyprexa label on September 16, 2003. See Zyprexa Package Insert (Sept. 16, 2003). At the FDA's request, on March 1, 2004, it sent a "Dear Doctor" letter to physicians in the United States informing them of the 2003 label change. See In re Zyprexa Prods. Liab. Litig., 253 F.R.D. at 134-36.
In November 2003, the American Diabetes Association, American Psychiatric Association, American College of Clinical Endocrinologists, and the North American Association for the Study of Obesity convened a consensus development conference (the "ADA consensus conference") on the subject of the association between antipsychotic drugs and diabetes. An eight-member panel heard presentations from fourteen experts drawn from the fields of psychiatry, obesity, and diabetes, FDA representatives, and atypical antipsychotic drug manufacturers. The panel reviewed the relevant peer-reviewed English language scientific articles.
The ADA consensus conference concluded that Zyprexa and Clozaril posed an increased risk of diabetes as compared to other atypical antipsychotic drugs. The consensus statement produced by the conference declared that these relative risks as well as advantages of the drugs for individual patients in a heterogeneous population "should ... influence drug choice." In part, its report concluded:
American Diabetes Association, et al., Consensus Development Conference on Antipsychotic Drugs and Obesity and Diabetes, 27 Diabetes Care 596, 596-97 (Feb. 2004)
On March 27, 2007, the FDA raised new concerns about the adequacy of Zyprexa's warning label in a letter to Lilly:
In re Zyprexa Prods. Liab. Litig., 253 F.R.D. at 141 (quoting Letter from Thomas Laughren, FDA, to Robin Pitts Wojcieszek, Eli Lilly & Co., Mar. 27, 2007).
A universally applicable date from which the statute of limitations is to be considered to run on an individual Zyprexa user's claim has not been determined. Numerous events represent moments at which a patient, health care provider, institution, or the medical community at large arguably discovered that the cause of an alleged injury may have been the administration of Zyprexa. The evidence in this mass litigation, including medical records and the depositions of numerous doctors, suggests that it was widely known and understood in the late 1990s among treating and prescribing physicians that weight gain might follow the administration of Zyprexa. The association between weight gain and heightened risk of diabetes was also broadly recognized by that time.
Formal events bringing this information to the medical profession include the September 2003 Zyprexa label change and contemporaneous press release, the 2003 consensus statement of the American Diabetes Association, and the March 2004 "Dear Doctor" letter distributed nationwide to physicians by Lilly.
In its June 2007 memorandum, order, and judgment on four motions for summary judgment in individual Zyprexa injury cases, this court found that, for purposes of these motions, the March 1, 2004 "Dear Doctor" letter would be considered the latest possible date on which members of the medical community knew or should have known about Zyprexa's obesity-and diabetes-related risks to patient health. See Souther v. Eli Lilly & Co. (In re Zyprexa Prods. Liab. Litig.), 489 F.Supp.2d 230, 278 (E.D.N.Y. 2007). In Souther, applying the relevant "learned intermediary" doctrine, it was determined that the claim of one of the plaintiffs was barred by the statute of limitations:
Id. (emphases added; citations to record omitted).
The March 1, 2004 date represents the "latest possible date" prescribing physicians and, in effect, their patients are deemed aware of the potential causal connection between Zyprexa and diabetes and from which the statute of limitations may run as to any individual plaintiff. Nevertheless, a fact-specific analysis is necessary for each case to determine when the plaintiff — whether independently or by operation of the learned intermediary doctrine — knew of the potential causal connection between Zyprexa and adverse health effects. The facts in many individual cases indicate a much earlier date of discovery for purposes of the statute of limitations. See, e.g., Appendices A-D of Souther v. Eli Lilly & Co. (In re Zyprexa Prods. Liab. Litig.), Nos. 04-MD-1596, 06-CV-I729, Docket Entries Nos. 88-1 to 88-4 (E.D.N.Y. June 11, 2007) (including relevant depositions demonstrating doctors' awareness of Zyprexa's association with patient weight gain).
Frederick Greaves, fifty-six years of age, has exhibited symptoms of severe mental illness since his early teens. See Def.'s Statement of Undisputed Material Facts ("Def.'s Rule 56.1 Stmt") ¶¶ 1-2. His documented mental health history includes bipolar disorder, schizoaffective disorder, major depression, and anxiety. Id. ¶ 3. He has been treated with a variety of medications, and he has been hospitalized multiple times because of his psychiatric problems and because of substance abuse. Id. ¶¶ 3-4.
Plaintiff first received Zyprexa in 1998, while undergoing inpatient treatment for drug addiction at the Kent County Mental Health Center in Warwick, Rhode Island. Id. ¶ 5. Zyprexa proved helpful for him, and in April 2004, Dr. Richard Whalen, M.D., a psychiatrist at the Kent County Medical Center, took over plaintiff's care and continued him on Zyprexa. Id. ¶¶ 6-7.
In May 2004, Dr. Whalen discussed the potential side effects of Zyprexa—including weight gain, hyperglycemia, and diabetes—with Mr. Graves, and obtained his informed consent to continue prescribing the medication. Similar meetings were held in February 2005 and March 2006. Id. ¶¶ 12-13.
Because of the risk of hyperglycemia, Dr. Whalen monitored plaintiffs blood glucose levels during the course of treatment, and coordinated treatment for plaintiff with plaintiffs primary care physician. He continued to prescribe Zyprexa to Mr. Greaves because he believed the benefits of doing so outweighed the risks. See id ¶ 14.
Dr. Whalen similarly monitored Mr. Greaves' weight during the course of his treatment with Zyprexa; in October 2005, he reduced plaintiffs Zyprexa dosage after Mr. Greaves gained weight. Id ¶ 15.
In the fall of 2006, Mr. Greaves' blood glucose levels were extremely high. Dr. Whalen became concerned that Mr. Greaves might have developed diabetes, and urged him to meet with his primary care physician. He again reduced plaintiffs Zyprexa dosage, but chose not to discontinue him on the medication. Id ¶¶ 16-17.
In November 2006, plaintiff was diagnosed with diabetes. In September 2007, plaintiffs Zyprexa use was discontinued, and he was prescribed Abilify. Id. ¶¶ 18-19 & n.21.
Summary judgment is appropriate only if "there is no genuine issue as to any material fact and if the moving party is entitled to judgment as a matter of law." Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 250 (1986); see, e.g., Mitchell v. Washingtonville Cent. Sch. Dist., 190 F.3d 1, 5 (2d Cir. 1999). Summary judgment is warranted when after construing the evidence in the light most favorable to the non-moving party and drawing all reasonable inferences in its favor, there is no genuine issue as to any material fact. Fed. R. Civ. P. 56(c); see Anderson, 477 U.S. at 247-50, 255.
The burden rests on the moving party to demonstrate the absence of a genuine issue of material fact. Goenaga v. March of Dimes Birth Defects Found., 51 F.3d 14, 18 (2d Cir. 1995); see, e.g., Celotex Corp. v. Catrett, 477 U.S. 317, 322-23 (1986). If the moving party appears to meet this burden, the opposing party must produce evidence that raises a question of material fact to defeat the motion. See Fed. R. Civ. P. 56(c). This evidence may not consist of "mere conclusory allegations, speculation or conjecture." Cifarelli v. Vill. of Babylon, 93 F.3d 47, 51 (2d Cir. 1996); see Del. & Hudson Ry. v. Cansol. Rail Corp., 902 F.2d 174, 178 (2d Cir. 1990) ("Conclusory allegations will not suffice to create a genuine issue.").
A multidistrict litigation transferee court applies the choice of law and statute of limitations rules of the state in which the action was filed. Menowitz v. Brown, 991 F.2d 36, 40 (2d Cir. 1993) (citing Van Dusen v. Barrack, 376 U.S. 612 (1964)). Because the instant action was originally commenced in this court, New York's choice of law principles apply.
Under New York law, the court applies interest analysis to determine which jurisdiction has the greatest interest in having its law applied to the case. Padula v. Lilarn Properties Corp., 644 N.E.2d 1001, 1002 (N.Y. 1994).
In this case, plaintiff is a resident of Rhode Island, and all relevant conduct took place in that state. Mr. Greaves was prescribed Zyprexa in Rhode Island, all of his known physicians practice in that state, and he was hospitalized there. Because Rhode Island is the only state with a legitimate interest in the resolution of this litigation, the court will apply that state's law to adjudicate plaintiffs claims.
Plaintiffs complaint rests on the basic allegation that Lilly negligently failed to warn him about the risks of Zyprexa.
"Essential to the court's analysis on this motion for summary judgment is the `learned intermediary' doctrine, which provides that (l) that manufacturers of prescription drugs and medical devices discharge their duty to of care to patients by providing adequate warnings to prescribing physicians, and (2) that any failure to warn cannot be considered a proximate cause of a subsequent injury if the physician was fully aware of the dangers that would have been included in an alternative warning." Shepherd v. Eli Lilly & Co. (In re Zyprexa Prods. Liab. Litig.), Nos. 04-MD-1596; 10-CV-1757, 2011 WL 2516333, at *4 (E.D.N.Y. June 23, 2011).
The learned intermediary defense is an
Souther, 489 F. Supp. 2d at 244. There is a strong trend in prescription drug failure-to-warn cases to reiterate and apply this well-established doctrine. See, e.g., Dietz v. Smithkline Beecham Corp., 598 F.3d 812, 816 (11th Cir. 2010) (concluding that summary judgment was proper where the "doctor provided explicit, uncontroverted testimony that, even when provided with the most current research and FDA mandated warnings, he still would have prescribed [the drug]. ... Pursuant to Georgia's learned intermediary doctrine, this assertion severs any potential chain of causation."); Motus v. Pfizer Inc., (Roerig Div.), 358 F.3d 659, 661 (9th Cir. 2004) (holding that "a product defect claim based on insufficient warnings cannot survive summary judgment if stronger warnings would not have altered the conduct of the prescribing physician") (citing Plummer v. Lederle Labs., 819 F.2d 349, 358-59 (2d Cir. 1987)); Ebel v. Eli Lilly & Co., 536 F.Supp.2d 767 (S.D. Tex. 2008) (granting summary judgment for defendant upon finding that prescribing physician was aware of Zyprexa's suicide-related risks that an adequate warning would have provided and that plaintiff had presented no evidence physician would not have prescribed Zyprexa had defendant provided him with an alternate warning label), aff'd, 321 F. App'x 350 (5th Cir. 2009) (per curiam); Allgood v. Glaxo Smith Kline PLC, No. 06-3506, 2008 WL 483574, at *3 (E.D. La. Feb. 20, 2008) (granting summary judgment for defendant because plaintiff had failed to show (1) that defendant did not adequately warn the physician of a risk associated with the drug that was not otherwise known to the physician and (2) that the "failure to warn the physician was both a cause in fact and the proximate cause of the plaintiff's injury"), aff'd sub nom. Allgood v. SmithKline Beecham Corp., 314 F. App'x 701 (5th Cir. 2009) (per curiam).
The learned intermediary doctrine "has been neither adopted nor rejected in Rhode Island." Hogan v. Novartis Pharms. Corp., No. 06-CV-0260, 2011 WL 1533467, at *9 (E.D.N.Y. Apr. 24, 2011). In this situation, the court's duty is to "carefully predict" how the Rhode Island Supreme Court would resolve the question, giving appropriate weight to pronouncements of the state's highest court and proper regard to relevant rulings of the state's lower courts. See Runner v. NY. Stock Exch., 568 F.3d 383, 386 (2d Cir. 2009).
The learned intermediary doctrine has been adopted by "almost every state." Susan Poser, Unlabeled Drug Samples and the Learned Intermediary: The Case for Drug Company Liability Without Preemption, 62 Food & Drug L.J. 653, 654 (2007). The court has found nothing in Rhode Island law to suggest that the Rhode Island Supreme Court would not adopt the learned intermediary doctrine iffaced with the question of whether to do so. It is highly likely that the Rhode Island Supreme Court will accept the general common and statutory law in this country with respect to a physician's responsibilities to protect his or her patient. Cf. Hogan, 2011 WL 1533467, at *9-10. In any event, given the circumstances of this case, and the notoriety of the Zyprexa litigation in the medical profession, the manufacturer has a right to rely on the physician's carrying out of the duty to warn the patient of clearly perceived dangers.
Application of the learned intermediary doctrine is therefore appropriate in this case.
Mr. Greaves was first prescribed Zyprexa in 1998, and he continued to take the medication until September 2007. Dr. Whalen, plaintiffs prescribing psychiatrist, knew that potential side effects of Zyprexa use included weight gain and diabetes, see Def.'s Rule 56.1 Stmt ¶ 8, and he testified that, despite the risks of Zyprexa, he believed that his decision to prescribe the medication to plaintiff was the correct one, id. ¶ 20. There is no evidence that Dr. Whalen would have altered his prescription decision had the warning that accompanied Zyprexa been different.
Because there is no evidence that plaintiffs doctor would have altered his prescription decision had he been provided additional information, summary judgment against the plaintiff is granted.
SO ORDERED.
